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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K153537
Device Name Sol-M Insulin Syringe, Sol-M TB Syringe
Applicant
Sol-Millennium Medical, Inc.
1735 N. Brown Rd., Suite 100
Lawrenceville,  GA  30043
Applicant Contact Jim Barley
Correspondent
Sol-Millennium Medical, Inc.
1735 N. Brown Rd., Suite 100
Lawrenceville,  GA  30043
Correspondent Contact Jim Barley
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/10/2015
Decision Date 06/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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